510(k) K161102

Nanostim Introducer Kit by St. Jude Medical, Inc. — Product Code DYB

K161102 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Inc. for the device "Nanostim Introducer Kit". The FDA issued a decision of Substantially Equivalent on May 19, 2016. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. St. Jude Medical, Inc. has at least 10 other 510(k) clearances on record.